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Equipment
GLP study equipment, including computerized systems, used to
generate, measure, or assess data and equipment used for environmental control
will be of appropriate design and adequate capacity to function according to
the requirements of the GLP study protocol. Equipment used in GLP studies will
be readily available for operation, inspection, cleaning, maintenance, and will
be tested, calibrated, and or standardized according to approved SOP.
Each department engaged in GLP studies will retain records
of inspection, maintenance, testing, calibration and/or standardization for
equipment used in GLP studies according to the GLP regulations. Equipment
approved for use in GLP studies will be clearly identified with a label affixed
to the equipment.
Equipment provided by sponsors and leased equipment must
meet all GLP requirements. Study participants operating equipment, including
sponsor personnel, must be trained on equipment use and will have documentation
of training on the operation, inspection, cleaning, maintenance, testing,
calibration and/or standardization as applicable.
Computerized systems that create, modify, maintain, archive, retrieve or distribute raw data for analysis will be of appropriate design and adequate capacity to function according to the study protocol and intended use in regulated studies.